Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 18 Years to 75 Years
Item
Alter 18 bis 75 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Histologically confirmed, primary only with laryngectomy respectable squamous-cell carcinoma of the larynx or hypopharynx
Item
Histologically confirmed, primary only with laryngectomy respectable squamous-cell carcinoma of the larynx or hypopharynx
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
CL414904 (UMLS CUI 2011AA)
C0023065 (UMLS CUI 2011AA)
72791001 (SNOMED CT 2011_0131)
10023872 (MedDRA 14.1)
30 (ICD-9-CM Version 2011)
C0007137 (UMLS CUI 2011AA)
28899001 (SNOMED CT 2011_0131)
10041823 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0023078 (UMLS CUI 2011AA)
4596009 (SNOMED CT 2011_0131)
MTHU015048 (LOINC Version 232)
C0020629 (UMLS CUI 2011AA)
81502006 (SNOMED CT 2011_0131)
T3-T4a carcinoma of the glottis
Item
T3-T4a carcinoma of the glottis
boolean
C0475374 (UMLS CUI 2011AA)
14410001 (SNOMED CT 2011_0131)
C0475751 (UMLS CUI 2011AA)
65565005 (SNOMED CT 2011_0131)
C0740083 (UMLS CUI 2011AA)
372103002 (SNOMED CT 2011_0131)
10018395 (MedDRA 14.1)
T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if applicable by root of tongue segmental resection
Item
T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if applicable by root of tongue segmental resection
boolean
C0475373 (UMLS CUI 2011AA)
67673008 (SNOMED CT 2011_0131)
C0475374 (UMLS CUI 2011AA)
14410001 (SNOMED CT 2011_0131)
C0475751 (UMLS CUI 2011AA)
65565005 (SNOMED CT 2011_0131)
C1299240 (UMLS CUI 2011AA)
372105009 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0023065 (UMLS CUI 2011AA)
72791001 (SNOMED CT 2011_0131)
10023872 (MedDRA 14.1)
30 (ICD-9-CM Version 2011)
C0226958 (UMLS CUI 2011AA)
47975008 (SNOMED CT 2011_0131)
CL421466 (UMLS CUI 2011AA)
T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example T2, post cricoidal) and hypopharynx segmental resection
Item
T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example T2, post cricoidal) and hypopharynx segmental resection
boolean
C0475373 (UMLS CUI 2011AA)
67673008 (SNOMED CT 2011_0131)
C0475374 (UMLS CUI 2011AA)
14410001 (SNOMED CT 2011_0131)
C0475751 (UMLS CUI 2011AA)
65565005 (SNOMED CT 2011_0131)
C0153398 (UMLS CUI 2011AA)
448665005 (SNOMED CT 2011_0131)
10021042 (MedDRA 14.1)
C13 (ICD-10-CM Version 2010)
148.9 (ICD-9-CM Version 2011)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0023065 (UMLS CUI 2011AA)
72791001 (SNOMED CT 2011_0131)
10023872 (MedDRA 14.1)
30 (ICD-9-CM Version 2011)
C0475373 (UMLS CUI 2011AA)
67673008 (SNOMED CT 2011_0131)
C0852722 (UMLS CUI 2011AA)
10036334 (MedDRA 14.1)
C0020629 (UMLS CUI 2011AA)
81502006 (SNOMED CT 2011_0131)
CL421466 (UMLS CUI 2011AA)
N-status: cervical metastases (N <=3) have to be rehabilitate by surgical procedures
Item
N-status: cervical metastases (N <=3) have to be rehabilitate by surgical procedures
boolean
C0027530 (UMLS CUI 2011AA)
45048000 (SNOMED CT 2011_0131)
MTHU002688 (LOINC Version 232)
C0027627 (UMLS CUI 2011AA)
128462008 (SNOMED CT 2011_0131)
10027449 (MedDRA 14.1)
C0441959 (UMLS CUI 2011AA)
62455006 (SNOMED CT 2011_0131)
C0441962 (UMLS CUI 2011AA)
53623008 (SNOMED CT 2011_0131)
C0441960 (UMLS CUI 2011AA)
46059003 (SNOMED CT 2011_0131)
C0441961 (UMLS CUI 2011AA)
5856006 (SNOMED CT 2011_0131)
C0034991 (UMLS CUI 2011AA)
52052004 (SNOMED CT 2011_0131)
10057374 (MedDRA 14.1)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
Blood count: Leukocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes > 8000/ mm\3
Item
Blood count: Leukocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes > 8000/ mm\3
boolean
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0200633 (UMLS CUI 2011AA)
30630007 (SNOMED CT 2011_0131)
10029363 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
Clinical chemistry:
Item
Clinical Chemistry Finding
boolean
C2347783 (UMLS CUI 2011AA)
adequate renal function, defined by serum creatinine and urea not >25% upper NL, creatinine-clearance > 60 ml/min/1,72 m\2
Item
adequate renal function, defined by serum creatinine and urea not >25% upper NL, creatinine-clearance > 60 ml/min/1,72 m\2
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0455273 (UMLS CUI 2011AA)
273967009 (SNOMED CT 2011_0131)
C1519815 (UMLS CUI 2011AA)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
adequate hepatic function with SGOT, SGPT not >50% and bilirubin not >upper NL
Item
adequate hepatic function with SGOT, SGPT not >50% and bilirubin not >upper NL
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
electrolytes at NL
Item
Electrolytes normal
boolean
C0438240 (UMLS CUI 2011AA)
166685005 (SNOMED CT 2011_0131)
anesthetic risk normal or low-grade elevated
Item
anesthetic risk normal or low-grade elevated
boolean
C0002903 (UMLS CUI 2011AA)
399248000 (SNOMED CT 2011_0131)
10067564 (MedDRA 14.1)
MTHU035920 (LOINC Version 232)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0205307 (UMLS CUI 2011AA)
17621005 (SNOMED CT 2011_0131)
N (HL7 V3 2006_05)
C0750482 (UMLS CUI 2011AA)
425404009 (SNOMED CT 2011_0131)
CL414623 (UMLS CUI 2011AA)
age 18-75 years
Item
Alter 18-75 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
effective contraception after individual advice for men and women if there is a possibility of reproductive potential (effective contraception are: oral contraception with estrogen and gestagen (no minipill), vaginal ring, contraception patch, estrogen free ovulation suppressors, hormone spiral with progesterone, injection for three month with depot gestagen, hormone releasing implantation (luteal hormone containing rod), abstinence or sterilization (vasectomy) of the male)
Item
effective contraception after individual advice for men and women if there is a possibility of reproductive potential (effective contraception are: oral contraception with estrogen and gestagen (no minipill), vaginal ring, contraception patch, estrogen free ovulation suppressors, hormone spiral with progesterone, injection for three month with depot gestagen, hormone releasing implantation (luteal hormone containing rod), abstinence or sterilization (vasectomy) of the male)
boolean
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C2911105 (UMLS CUI 2011AA)
Z71.9 (ICD-10-CM Version 2010)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0014939 (UMLS CUI 2011AA)
41598000, 61946003 (SNOMED CT 2011_0131)
MTHU003480 (LOINC Version 232)
C0033306 (UMLS CUI 2011AA)
116614001, 20249007 (SNOMED CT 2011_0131)
C0042260 (UMLS CUI 2011AA)
CL424926 (UMLS CUI 2011AA)
C0029968 (UMLS CUI 2011AA)
C0419518 (UMLS CUI 2011AA)
312082008 (SNOMED CT 2011_0131)
10009849 (MedDRA 14.1)
C0033308 (UMLS CUI 2011AA)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0033306 (UMLS CUI 2011AA)
116614001, 20249007 (SNOMED CT 2011_0131)
C0021902 (UMLS CUI 2011AA)
C0591309 (UMLS CUI 2011AA)
50318003 (SNOMED CT 2011_0131)
MTHU003615 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C1705186 (UMLS CUI 2011AA)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0024559 (UMLS CUI 2011AA)
399141000 (SNOMED CT 2011_0131)
10065591 (MedDRA 14.1)
63.70 (ICD-9-CM Version 2011)
C0042387 (UMLS CUI 2011AA)
22523008 (SNOMED CT 2011_0131)
10047133 (MedDRA 14.1)
63.73 (ICD-9-CM Version 2011)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
primary cancer treatable by operational larynx-conserving procedures
Item
primary cancer treatable by operational larynx-conserving procedures
boolean
C1306459 (UMLS CUI 2011AA)
372087000 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0189204 (UMLS CUI 2011AA)
387636004 (SNOMED CT 2011_0131)
10062034 (MedDRA 14.1)
C0459914 (UMLS CUI 2011AA)
281131004 (SNOMED CT 2011_0131)
distant metastases (M1-Status)
Item
distant metastases (M1-Status)
boolean
CL278860 (UMLS CUI 2011AA)
C0441971 (UMLS CUI 2011AA)
55440008 (SNOMED CT 2011_0131)
total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of surrounding soft tissues respectively the esophageal aditus (exclusive cartilage infiltration represents no exclusion criteria)
Item
total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of surrounding soft tissues respectively the esophageal aditus (exclusive cartilage infiltration represents no exclusion criteria)
boolean
C0475276 (UMLS CUI 2011AA)
258261001 (SNOMED CT 2011_0131)
C0023078 (UMLS CUI 2011AA)
4596009 (SNOMED CT 2011_0131)
MTHU015048 (LOINC Version 232)
C0521324 (UMLS CUI 2011AA)
C0332448 (UMLS CUI 2011AA)
47351003 (SNOMED CT 2011_0131)
C0225317 (UMLS CUI 2011AA)
87784001 (SNOMED CT 2011_0131)
MTHU016974 (LOINC Version 232)
C1522619 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0007301 (UMLS CUI 2011AA)
309312004 (SNOMED CT 2011_0131)
C0332448 (UMLS CUI 2011AA)
47351003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
CL425201 (UMLS CUI 2011AA)
tumor-specific prior chemo- or radiotherapy
Item
tumor-specific prior chemo- or radiotherapy
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
metachronous or synchronous malignant tumor (exception basalioma) [in case of a controlled tumor of different localization with a non-treated interval over 5 years to the present therapy the patient can be included after consultation with the coordinating investigator]
Item
metachronous or synchronous malignant tumor (exception basalioma) [in case of a controlled tumor of different localization with a non-treated interval over 5 years to the present therapy the patient can be included after consultation with the coordinating investigator]
boolean
C1334703 (UMLS CUI 2011AA)
C0027663 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
CL425202 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0475264 (UMLS CUI 2011AA)
257880008 (SNOMED CT 2011_0131)
life expectancy < 3 month
Item
Life expectancy
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
Karnofsky performance status < 70%
Item
Karnofsky performance status <70%
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV according NYHA status, myocardial infarction, angina pectoris, respiratory global insufficiency)
Item
serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV according NYHA status, myocardial infarction, angina pectoris, respiratory global insufficiency)
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0034072 (UMLS CUI 2011AA)
83291003, 274096000 (SNOMED CT 2011_0131)
10010971 (MedDRA 14.1)
I27.81 (ICD-10-CM Version 2010)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C2348867 (UMLS CUI 2011AA)
C0035229 (UMLS CUI 2011AA)
409623005 (SNOMED CT 2011_0131)
10038701 (MedDRA 14.1)
Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid arthritis)
Item
Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid arthritis)
boolean
C0008679 (UMLS CUI 2011AA)
27624003 (SNOMED CT 2011_0131)
C0205355 (UMLS CUI 2011AA)
6934004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
recurrent pneumonia, COPD GOLD stage <2, chronic inflammation of intestine or any other concomitant diseases, which disallow study participation in the opinion of the responsible physician
Item
recurrent pneumonia, COPD GOLD stage <2, chronic inflammation of intestine or any other concomitant diseases, which disallow study participation in the opinion of the responsible physician
boolean
C0694550 (UMLS CUI 2011AA)
10066727 (MedDRA 14.1)
C0024117 (UMLS CUI 2011AA)
13645005 (SNOMED CT 2011_0131)
10009033 (MedDRA 14.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
C1856359 (UMLS CUI 2011AA)
C0243087 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
CL415098 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
Other circumstances (contra-indications), which disallow treatment with Docetaxel, Cisplatin, 5-FU, Cetuximab or radiotherapy
Item
Other circumstances (contra-indications), which disallow treatment with Docetaxel, Cisplatin, 5-FU, Cetuximab or radiotherapy
boolean
C0852648 (UMLS CUI 2011AA)
10010833 (MedDRA 14.1)
C0699967 (UMLS CUI 2011AA)
386918005 (SNOMED CT 2011_0131)
C0008838 (UMLS CUI 2011AA)
387318005 (SNOMED CT 2011_0131)
MTHU016242 (LOINC Version 232)
C0016360 (UMLS CUI 2011AA)
387172005 (SNOMED CT 2011_0131)
MTHU016749 (LOINC Version 232)
C0995188 (UMLS CUI 2011AA)
409400001 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
Expected absent patient compliance
Item
Expected absent patient compliance
boolean
C1321605 (UMLS CUI 2011AA)
Periodic follow-up not possible (for example address outside germany)
Item
Periodic follow-up not possible (for example address outside germany)
boolean
C1522577 (UMLS CUI 2011AA)
Pregnant or breast-feeding woman
Item
Pregnant or breast-feeding woman
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Absent or constricted legal capacity
Item
Absent or constricted legal capacity
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0443288 (UMLS CUI 2011AA)
263856008 (SNOMED CT 2011_0131)
C0683673 (UMLS CUI 2011AA)
Participation to another clinical trial with any investigational study within 30 days prior to study screening
Item
Participation to another clinical trial with any investigational study within 30 days prior to study screening
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
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